NCT03728764

Growth and Safety of a Two-stage Feeding System in Preterm Infants

Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 5 Days
• Healthy volunteers: Accepted

Summary

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

Detailed description

This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.

Conditions

• Preterm Infant

Interventions

Type	Name	Description
OTHER	Preterm infant formula	Preterm infants will receive Stage 1 investigative product as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive stage 2 preterm formula from when 1.8 kg of body weight is achieved until 1 month after hospital discharge.

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-09-19
• Completion: 2019-12-15
• First posted: 2018-11-02
• Last updated: 2020-02-25

Locations

4 sites across 3 countries: Czechia, Poland, Slovakia